Pharmacokinetics and Safety of PBK-1801 After Single Oral Administration in Healthy Korean Women

Pharmbio Korea

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: PBK-1801

Study type

Interventional

Funder types

Industry

Identifiers

NCT04418388

PBK_1801_101

Details and patient eligibility

About

The primary objective of this study is to assess the pharmacokinetic characteristics after a single dose of oral PBK-1801 in healthy Korean women for preparing the bridging data for Koreans.

Enrollment

36 patients

Sex

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Body Mass Index (BMI) between 19 and 30 kg/m²
Subjects are to be in good general health according to medical history, physical examination, electrocardiograph (ECG) recording and clinical laboratory assessments showing no signs clinically significant pathology (A subject with a clinically insignificant abnormality may be included by the discretion of the investigator)
Subjects are to have given their written informed consent to participate in the study and to abide by study restrictions

Exclusion criteria

History or evidence of clinically significant cardiovascular, renal, hepatic, hematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological, psychiatric or other major disease
Subjects who have any condition possibly affecting drug absorption (e.g., previous surgery on the gastrointestinal tract other than uncomplicated appendectomy, inflammatory bowel disease).
History or current alcohol abuse or drug addiction
Subjects who for any reason, are deemed by the Investigator to be inappropriate for this study